A Phase 4 interventional study of amoxicillin plus clavulanic acid and amoxicillin plus clavulanic acid in Diverticulitis, sponsored by Consorci Sanitari de Terrassa. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Consorci Sanitari de Terrassa · Phase 4, Interventional, and Treatment
Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.
A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 50 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria (prerandomization):
Exclusion Criteria (postrandomization):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
Drug: amoxicillin plus clavulanic acid
Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days
Drug: amoxicillin plus clavulanic acid
Drug pages: Amoxicillin · Clavulanic Acid
intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days
Drug pages: Amoxicillin · Clavulanic Acid
intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days
failure of treatment
Time frame: the 4th day (group 1) or the 8th day (group 2)
emergency admission or hospital readmission for reasons related to the previous diverticulitis
Time frame: 30 days after discharge
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Amoxicillin · Clavulanic Acid
Consorci Sanitari de Terrassa